But what would the clinical impact of these proposals be? For most of them, we have no idea how many patients would be helped–or harmed.

Now we have some data, at least for one of these proposals. My colleagues and I just published a peer-reviewed analysis of "reciprocal approval," which would hasten Americans' access to new drugs already available in other countries (free full text here). Our historical review shows that rubber-stamping drugs approved elsewhere would have mainly benefitted a small number of U.S. patients with rare diseases, while likely exposing the wider population to additional safety risks.

U.S. FDA campus in Silver Spring, Md. (AP Photo/Andrew Harnik, File)

[Disclaimer: this post is solely authored by me, and reflects my views alone, not necessarily those of my co-authors in the published research.]

But the size of the potential clinical benefit has remained murky. Although Sen. Ted Cruz claims the reciprocal approval bill he co-sponsored would"unleash life-saving drugs and devices in the United States,"some industry-watchers have questioned how many medically important drugs would actually be affected (e.g., here, here, here and here). In addition, giving patients faster access to medicines could also lead to offsetting harms, if some drugs first available outside the U.S. and then reflexively approved here were later withdrawn due to safety concerns. (The legislation proposed by Sen. Cruz would give the FDA the option to deny reciprocal approval to drugs it deemed unsafe, but also grant Congress the right to overrule the agency's decision.)